Regulatory Affairs Manager

Job Summary

A company is looking for a Regulatory Affairs Manager.

Key Responsibilities

• Review and approve marketing/promotional materials for FDA compliance
• Provide regulatory guidance to Marketing teams to align with business goals
• Manage 2253 submissions and ensure timely filings

Required Qualifications

• Bachelor's degree in a scientific discipline preferred
• 5+ years of direct Regulatory Affairs Ad Prom review experience
• Experience with Promomats/Veeva Vault regulatory submission system
• Experience with FDA Form 2253 submissions
• 7+ years total Regulatory Affairs experience, with project/people management preferred